The purpose of this study is to treat HIV and HCV coinfected subjects with telaprevir, peg-interferon alfa-2a, and ribavirin to achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug.

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

Proportion of subjects who achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug (sustained viral response [SVR12]) [ Time Frame: 12 weeks after the last planned dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects who achieve undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) [ Time Frame: 24 weeks after the last planned dose of study drug ] [ Designated as safety issue: No ]

CD4 counts and HIV-1 RNA meeting acceptable criteria at Screening as specified in the protocol.

Laboratory values within acceptable ranges at Screening as specified in the protocol

Exclusion Criteria:

Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1

Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides

Contraindications to any planned HAART component as per the respective drug labeling information

Contraindications to Peg IFN or RBV

Evidence of hepatic decompensation

Clinical suspicion of acute hepatitis

Any other cause of liver disease in addition to hepatitis C

History of organ transplantation (except cornea and skin)

Autoimmune-mediated disease

Participated in any investigational drug study within 90 days before Day 1

Previous treatment with an HCV protease inhibitor

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467479